The benefit of priority is hereby claimed under 35 U.S.C. Section 120, based on copending application U.S. Ser. No. 07/830,061, filed Feb. 3, 1992, for inventor James B. Osbon on an invention entitled "MALE ORGAN CONDITIONING APPLIANCE."
The present invention relates in general to improved apparatus and method for augmenting male potency and in particular to improved cincturing devices and methods which also provide improved comfort and safety during use of a vacuum erection chamber of the type having an open receiving end for receipt of a user's male sex organ.
Impotence, or sexual dysfunction, is a chronic and persistent problem among as much as 10 percent of the entire adult male population of the United States. Whether due to psychological or physical causes, impotence is the inability to achieve or maintain an adequate erection of the male sex organ, i.e., penis, for sexual intercourse.
The physical events of an erection are well known, and generally involve the inflow and retention of blood into certain cavernous bodies of the male sex organ so that it becomes stiff and erect, i.e., distended. As the stimulated condition subsides, natural processes cause (or permit) the blood to drain from the cavernous bodies of the penis and the penis again becomes flaccid.
The foregoing facts have resulted in efforts for many years to treat impotence through the use of various cincturing or tourniquet like devices. Generally speaking, such devices may typically comprise a circular element received about the male sex organ, such as at its base or root, for supplementing the natural forces which restrict the egress of blood from engorged penile cavities. Various elastic rings or the like are known for such purposes. See for example, Chaney (U.S. Pat. No. 4,539,980), which discloses a generally circular elastic ring with attached handles to function as a male organ conditioner by being applied to the root of a penis for securing an engorged condition thereof.
While such technology has addressed the problem of maintaining or securing a penile erection, another facet of the impotence problem which has been long addressed is the initial inducement or production of a suitable erection. For example, the above-referenced Chaney '980 patent suggests the use of a massaging action below or behind the scrotum to induce a forward blood flow into the penis, overcoming restrictive radially inward compressive forces of the elastic ring already applied to the base of the flaccid penis. In other words, it is intended that blood be manually massaged passed the elastic ring at the base of the penis with such ring then acting as a check valve.
Improvements to the foregoing apparatus and methodology for achieving (and sustaining) penile erection have been sought. One major alternative to the use of surgical treatments such as penile prosthetic implants or vascular reconstructive surgery, has been vacuum erection enhancement therapy. Vacuum erection device therapies operate on the principle that a suitable erection can be obtained by placing the user's penis into an open receiving end of a vacuum chamber or cylinder which then with vacuum force draws blood into the cavernous bodies of the penis. Once produced, the vacuum induced erection may be captured, i.e.. maintained, by use of cincturing devices as referenced above, for example elastic constriction rings.
While no form of medical treatment can ever be expected to be 100 percent effective, generally speaking, vacuum tumescence enhancement therapy is a favorable treatment for a number of reasons. For example, it will not interfere with other treatments, there are no permanent implants, it can be discontinued at any time, it is relatively inexpensive, and it is highly effective and carries a relatively high success rate.
One potentially negative aspect of the use of vacuum erection devices and such therapy is a natural consequence of the fact that human sexual organs are naturally highly sensitive regions of the body which could be harmed by improperly applied or excessive vacuum forces. For example, the penis is a highly vascular and sensitive organ which can respond differently to a given amount of vacuum force from one patient to another. One reason for this is simply due to the variety in specific sizes of the human anatomy, including differential variations between flaccid and erect states of the male sex organ, and other variables and factors which can limit optimum matching of the vacuum therapy equipment with a given patient's physical condition.
In addition to the sensitivity of the penis, interaction with the next physically adjacent sexual features is possible during vacuum erection therapy. More specifically, the scrotum is a pouch of relatively loose skin which projects from the lower part of the abdominal wall just below the base of the penis. The scrotum has two lateral portions for enclosing and respectively supporting in suspension the testes, generally oval organs averaging from about 4 to about 5 centimeters in length. The testes are essential male sex organs of reproduction which have the dual functions of producing spermatozoa and the male sex hormone testosterone. The spermatozoa are stored in a mass of coiled tubing referred to as the epididymis, which is also protectively received in the scrotum. Spermatozoa are forwarded from the epididymis to the ductus deferens, from which the sperm reach the ejaculatory duct and are expelled from the male sex organ through the urethra.
The significance of the foregoing physical anatomy is that such all important organs are received in suspension in the relatively loose folds of the skin comprising the scrotum. However, the proximity of the scrotal and other abdominal wall tissue or skin adjacent to the base of the penis brings such anatomy into close proximity with the open receiving end of a vacuum erection device applied to a user's penis. Therefore, there is the potential for highly undesirable intake of skin, i.e., scrotal or abdominal tissue, into the vacuum erection chamber during vacuum therapy. This scrotal tissue intake, depending on the degree or time extent thereof, is not necessarily harmful to the important sexual organs described above and contained in the scrotum, but certainly has the capacity to reduce the comfort level of the male subject. Given the nature of the therapy involved, and the frequent psychological implications of both the condition and the therapy selected, discomfort levels of the user could result in a disproportionate response level of anxiety or of loss or questioning of confidence in the therapy chosen, all of which is highly undesirable and at cross purposes to the overall therapy.
The considerable variety of devices previously available for the intended purpose of maintaining penile erections have considered a variety of attendant problems associated with the use of such devices. For example, the device must be applied to the user and in some fashion secured thereto (as well as subsequently removed therefrom). However, such devices have typically not acknowledged or addressed the specific problem of scrotal or abdominal tissue intake during vacuum erection therapy, especially since not all such devices are even intended for use in conjunction with such form of therapy, but many rather are intended to capture natural or manually produced erections.
Many prior art devices have typically comprised a generally circular or round securement member designed to be received at some point about the user's penis, typically at the base or root of the penis. Other elements or features have been secured to or project from such ring-like cincture element. Various functions have been performed by such features, such as providing structure or a base for attachment of the device to the user or to some other device, providing a structural foundation or strengthening for the device, performing hygienic purposes such as a disease shield, or performing purely mechanical functions such as serving as handles. Various examples of such prior art devices are disclosed in the following exemplary United States patents: Osbon, U.S. Pat. Nos. Des. 317,505 and Des. 317,504; Sorkin et al.. U.S. Pat. No. 4,856,534; Knapps, U.S. Pat. No. 4,724,829; Hanus. U.S. Pat. No. 4,240,413; Cray, U.S. Pat. No. 3,759,253; Gauthier, U.S. Pat. No. 3,705,580; Macchioni, U.S. Pat. No. 3,621,840; Clark, U.S. Pat. No. 3,455,301; Nelson. U.S. Pat. No. 1,608,806; and Henderson, U.S. Pat. No. 1,133,958.
Osbon (U.S. Pat. No. 4,856,498) commonly assigned with the subject application discloses a vacuum generating and constriction apparatus for augmenting male potency. Acknowledged therein is a scrotal tissue intake problem, i.e., the possibility of scrotal tissue being drawn up into a vacuum cylinder and causing user discomfort. The Osbon '498 patent proposes to address the tissue intake problem by providing adapter inserts of differing internal diameters to be selected and used in the open receiving end of the vacuum erection chamber. In other words, it is intended to reduce the number of physical conditions which could result in tissue intake by more closely matching the size of the vacuum structure inside diameter to the size of the outside diameter of the male sex organ anatomy involved. While effective to an extent with use of such structure, such approach does not avail patients who have vacuum erection chambers which are not designed to receive such adapter inserts, or whose physical anatomy is incompatible with being more closely matched by the use of adapter inserts to the chambers which they use.
The above-referenced Osbon '498 patent further discloses a therapeutic use of an additional or second vacuum step so as to partially increase penile engorgement after a constriction band has been placed on the base of an organ. As described therein, a constriction band such as shown in FIG. 4 of the '498 patent is elastic in nature and has specifically designed handle means which at rest remain in close relationship to the ring. After the ring is applied to the base of a male sex organ for capturing a certain level of induced engorgement thereof, the male sex organ is reintroduced (or introduced) into a vacuum chamber with both the ring and the particularly designed handles received inside the open receiving end of the vacuum chamber. Thereafter, an additional level of vacuum induced engorgement may be obtained with the constriction ring in place. Such supplemental or second vacuum step constitutes a second opportunity for the occurrence of scrotal tissue intake. Addressing such possibility once the penis is enlarged to a certain extent and in receipt of a constriction ring thereon could require the patient to change to an adapter insert of a different size (assuming that the patient has available in the first place a vacuum erection chamber with adapter insert features).
Perry (U.S. Pat. No. 4,641,638) discloses an alternative to use of an elastic member for cincturing an engorged penile condition. A prosthetic device of fixed outside diameter comprises a tubular sleeve element which is applied to the base of the male sex organ. An insertion device with a suction cup-like member may be attached to the tip of a flaccid male sex organ and used to draw the organ outward for reciprocation of the tubular element along the length of the penis to be seated at its base.
In the Perry device, the inside diameter of the tubular element includes an expandable diaphragm. The proximal end of the tubular device includes a flared flange portion through which passes an inlet opening which is in airflow communication with an internal generally annular air cavity defined between the expandable diaphragm and the fixed outside diameter of the tubular element. A flexible conduit connects to the opening at the base of the flared portion and further connects to an air pressure gauge, a check valve, and a hand pump mechanism. Once a sufficient amount of blood has entered the penis through normal physiological response, it is intended that the user throttle the valve accordingly and use the manual bulb pump to enlarge the expandable diaphragm (radially inward) and constrict the penis. However, it is instructed that before ejaculation during intercourse, the check valve must be manually manipulated to an open position so as to release the constriction of the expandable diaphragm and avoid the otherwise possibility of injury to the user.
The Perry patent describes an alternative to the natural erection process which involves an artificial vascularization comprising application of a vacuum chamber to the tubular member seated against the above-mentioned flared flange portion so as to supposedly eliminate air flow into the vacuum chamber from its open end. Once erection is obtained with the vacuum cylinder, the check valve and manual pump are again utilized to constrict the root of the penis. Likewise, again prior to ejaculation, the valve must be manipulated to release the constriction to otherwise prevent the occurrence of trauma during ejaculation due to natural physiologically increased vascularization of the penis just prior to ejaculation.
Whether relying on a natural physiological erection or an artificially induced erection, at all times the check valve and flexible tubing arrangement must remain in place and be attended to by the user in order for the Perry cincturing fixed outside diameter tubular member to function. Such operations clearly have the potential for interrupting normal intercourse activities and otherwise significantly detracting from the experience in comparison with a fully natural experience.
While the Perry arrangement makes use of a relatively nonelastic cincturing device intended for effecting a seal with an artificial vacuum erection chamber, there is apparently no specific acknowledgement or addressing of the need to protect sensitive surrounding tissue and organs. Another known device makes use of an elastic element for contributing to a seal with the vacuum chamber, but likewise apparently makes no specific acknowledgement of the potential problem of tissue vacuum intake. Specifically, the Mission Pharmacal Company of San Antonio, Tex. 78296, has marketed a penile constriction seal referred to under the name "SofTouch." Such constriction seal is described as having a central stem for restricting blood flow both to and from a user's penis and a flange for effecting a seal against a vacuum erection cylinder for the purpose of improving pump efficiency. The Mission Pharmacal Company constriction seal structure comprises a highly flexible simple annular flange of about 3.5 inches outside diameter with a central upright stem about 0.625 inches tall and having an inside diameter of only 0.375 inches (approximately the diameter of a pencil).
The Mission Pharmacal Company brochure materials describe two alternative approaches for seating the constriction seal about the base of the penis. One approach involves use of an applicator cone and annular applicator sleeve. Considerable and multiple applications of lubricant are made to the outside of the applicator cone and the inside of the seal stem. The flange is then used as handles to draw the elastic stem down around the applicator cone onto an associated applicator sleeve. The sleeve is then placed over the head of a penis in its flaccid or semi-flaccid state, and moved to the base of the penis, after which the seal is transferred from the sleeve onto the base of the penis. The flange portion is subsequently again used as handles for removal of the 0.375 inches diameter stem (unstretched measurement) from the penis.
The Mission Pharmacal Company brochures describe an alternative method of fitting the constriction seal onto the penis. The user is to insert the first two fingers of each hand into the 0.375 inch inside diameter stem and spread the opening of the stem. Continuing to hold the stem open, the flaccid or semi-flaccid penis is then to be inserted through the stem and the seal pulled against the base of the penis. Both the penis and the inside of the stem are to be lubricated prior to such seating efforts.
Aside from apparent difficulties in manipulation of the soft device with an initially relatively small inside diameter onto a user's penis, the Mission Pharmacal Company brochures also report clinical evaluations indicating a 43 percent negative rating as to whether the constriction seal provides a more effective seal for pumping. Such a highly negative rating would tend to indicate that such device does not provide an effective solution to the potential problem of tissue vacuum intake through use of an elastic device, which problem apparently is not expressly acknowledged by the Mission Pharmacal Company literature.
The complete disclosures of all of the above-referenced United States patents are fully incorporated herein by reference.